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ISLAMABAD: The Economic Coordination Committee (ECC) of the Cabinet has decided to amend the Import Policy Order (IPO) 2022 to allow government agencies to import pharmaceutical (allopathic) raw materials.

The Minister of Commerce in the summary informed the ECC meeting presided over by Finance Minister Ishaq Dar on Wednesday (June 21, 2023) that as per Import Policy Order 2022, import of pharmaceutical (allopathic) raw material of pharmaceutical grade in the form of unprocessed ingredients is allowed only to pharmaceutical industries holding a valid pharmaceutical manufacturing license.

The ECC added the proviso that “provided that if the oil adjuvant is to be imported by the federal/ provincial government or any other designated government institute/ agency, for the purpose of research/ production of vaccines, the same shall be allowed to be imported through registered/ authorised distributor of foreign principal/ supplier of pharmaceutical raw material, subject to research and production of vaccines for non-commercial purpose”.

Drug manufacturers seek urgent steps for raw material import

The meeting was informed that the Livestock and Dairy Development Department, Government of Punjab has informed that its Veterinary Research Institute (VRI) and Foot and Mouth Disease Research Centre (FMDRC) are dealing with research and manufacturing of veterinary vaccines to be used for controlling various prevalent diseases in livestock and poultry, especially Foot and Mouth Disease and Hemorrhagic Septicemia.

In order to procure 46,288-kgs of montanide oil, a primary ingredient for manufacturing of vaccines against said diseases, the department awarded work order to M/s Alternative Chemicals (Pvt) Limited Lahore.

Since M/s Alternative Chemicals (Pvt) Limited, Lahore was not an industrial user/ pharmaceutical manufacturer; therefore, it was not eligible to import montanide oil as per provisions of WO. 2022. Therefore, the Ministry of Commerce was requested to allow the import of montanide oil by M/s Alternative Chemicals (Pvt) Ltd, Lahore for onward supply to the government of Punjab in relaxation of the restrictions.

The ECC was informed that similar cases of the Punjab government were also submitted in 2017, 2019, 2020 and 2021, for one-time release of montanide oil for the manufacturing of veterinary vaccines.

Under IPO, 2022 the federal government is empowered to allow import of any product in relaxation of any prohibition or restriction as imposed under 1PO 2022 on a one-time release basis

However, allowing exemption on a yearly basis is not desirable, instead, appropriate policy amendment to cater for such cases of import is required.

Accordingly, the stakeholders were consulted to bring in necessary amendment in IPO, 2022 and during an Inter-Ministerial Meeting (IMM) comprising the representatives of the Ministry of Commerce, Ministry of National Health Services, Regulations and Coordination, the Federal Board of Revenue (FBR), the Drug Regulatory Authority of Pakistan (DRAP), and Livestock and Dairy Development Department, Government of the Punjab, the participants, unanimously, decided to amend IPO 2022.

The DRAP proposed that the minutes of the aforementioned inter-ministerial meeting may be re-worded in order to ensure that montanide adjuvant will be used for research and non-commercial purpose only.

The ECC was proposed that the proviso may be added that, “provided that if the oil adjuvant is to be imported by the federal/ provincial government or any other designated government institute/ agency, for the purpose of research/ production of vaccines, the same shall be allowed to be imported through registered/ authorised distributor of foreign principal/ supplier of pharmaceutical raw material, subject to research and production of vaccines for non-commercial purpose”.

The ECC was also informed that the necessary consultations as per the Rules of Business, 1973 have been done with the Ministry of National Health Services Regulations and Coordination and the FBR.

Copyright Business Recorder, 2023

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